Opko Health announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Rayaldee (calcifediol modified-release capsules) for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

The NDA is supported by data from three randomized, double-blind, placebo-controlled studies and one open-label extension study conducted in the targeted patient population. These studies met all primary efficacy and safety endpoints.